— According to Article 241 of the Code of the Republic of Kazakhstan “On the Health of the People and the Healthcare System,” “The quality assessment of medicinal products and medical devices registered in the Republic of Kazakhstan is carried out by determining the conformity of the quality of medicinal products and medical devices with the data of the registration dossier.”
Quality assessment is not conducted for individually imported (or manufactured) components that are part of medical devices and are not intended to be used as standalone products or devices, as well as for consumables specifically designed by the medical device manufacturer for use with the devices and which can only function with these consumables.